Terminé

The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients

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Ce qui est collecté

Collecte de données

Qui peut participer

Mycobacterium Avium-Intracellulare Infection

+ HIV Infections
À partir de 13 ans
Comment se déroule l'étude

Histoire Naturelle

Observation de l'évolution d'une maladie sans intervention médicale, afin de comprendre son déroulement et ses différentes phases.
Observationnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 24 juin 2005
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To determine if treatment of MAC infection in HIV-1 infected persons is associated with the decreases in plasma levels of TNF-alpha. Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities. Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities. All patients diagnosed with MAC and who will initiate at least a 2 drug clarithromycin containing MAC treatment regimen will be eligible for participation. Blood and urine will be obtained from each patient at the following timepoints: Pre-Entry (within 7 days prior to study entry), week 4, and week 8. Sites will process and ship specific samples to Case Western Reserve University (CWRU). Various assays and analyses will be performed by CWRU. NOTE: Patients will receive no treatment on this study, however, all patients must be receiving at least a 2 drug clarithromycin containing treatment regimen for MAC either as part of participation in other studies or as prescribed by the subject's health care provider.

Titre officielEffects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons. 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 24 juin 2005
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
24 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Histoire Naturelle
Ces études observent la façon dont une maladie évolue naturellement, sans traitement. Elles aident à comprendre son développement, ses effets dans le temps et son impact sur la qualité de vie.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 13 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry. Patients must have: * Documented HIV infection. * Either symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry. * Signed parental consent for patients less than 18 years of age. Prior Medication: Allowed: * Patients who have received presumptive or empiric antimycobacterial therapy prior to study entry may be enrolled if they have been treated for no more than 72 hours prior to study entry. * Patients who have been receiving prophylaxis with azithromycin, clarithromycin and/or rifabutin may be enrolled. * Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry. Required: * Patients must be on a stable antiretroviral regimen (same drug or combination drugs; dose modifications allowed) for at least 4 weeks prior to study entry. NOTE: * Patients will be requested NOT to modify or add new drugs to their stable ARV regimen for the duration of this study. Patients who absolutely require ARV changes at any time prior to week 8 will continue on study, however, their data will be analyzed separately. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Previous enrollment and permanent study drug discontinuation in ACTG 223. Note: * Co-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both studies must be simultaneous. * This protocol does not meet federal requirements governing prisoner participation in clinical trials and should not be considered by local IRBs for the recruitment of prisoners. Concurrent Medication: Excluded: * Cytokine inhibitors. * Corticosteroids. * Thalidomide. * Pentoxifylline or any other immunomodulator. * Any interleukin. * Colony stimulating factors (G-CSF or GM-CSF) Patients with the following prior conditions will be excluded: * Subjects who have had an opportunistic infection (other than MAC) within 14 days immediately preceding study entry. Prior Medication: Excluded within the 14 days immediately preceding study entry: * Cytokine inhibitors. * Corticosteroids. * Thalidomide. * Pentoxifylline or any other immunomodulator. * Any interleukin. * Colony stimulating factors (G-CSF or GM-CSF) Prior Treatment: Excluded: * Patients who have received a blood transfusion within the 14 days immediately preceding study entry.



Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 11 sites
Suspendu
San Francisco Gen HospSan Francisco, United StatesVoir le site
Suspendu
Univ of Colorado Health Sciences CtrDenver, United States
Suspendu
Washington Reg AIDS Prog / Dept of Infect DisWashington, United States
Suspendu
Northwestern Univ Med SchoolChicago, United States

Terminé11 Centres d'Étude